Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02446600 | Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 579 | — | — | Mar 28, 2016 | Mar 4, 2027 | May 4, 2026 | 356 | United States, Canada +2 |
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
| Arm | Type | Description |
|---|---|---|
| Arm I (platinum-based chemotherapy) | ACTIVE_COMPARATOR | See detailed description. |
| Arm II (olaparib) | EXPERIMENTAL | Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial. |
| Arm III (olaparib, cediranib maleate) | EXPERIMENTAL | Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Carboplatin | DRUG | Given IV |
| Cediranib Maleate | DRUG | Given PO |
| Computed Tomography | PROCEDURE | Undergo CT |
| Echocardiography Test | PROCEDURE | Undergo ECHO |
| Gemcitabine | DRUG | Given IV |
| Gemcitabine Hydrochloride | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA |
| Olaparib | DRUG | Given PO |
| Paclitaxel | DRUG | Given IV |
| Pegylated Liposomal Doxorubicin Hydrochloride | DRUG | Given IV |
| Pharmacological Study | OTHER | Correlative studies |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
Inclusion Criteria: * Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histolo...